WASHINGTON _ The Environmental Protection Agency (EPA) hasproposed a new system for screening genetically engineered microbialproducts under the Toxic Substance Control Act (TSCA). In theproposed rule, the EPA will retain oversight of intergenericmicroorganisms (formed by combining genetic material fromorganisms of different genera).Companies or individuals intending to produce or process intergenericmicroorganisms for commercial purposes would be required to notifythe EPA at least 90 days in advance of manufacture. The EPA wouldthen have 90 days to rule on whether the microorganism presents an"unreasonable risk to human health or the environment." A similarnotification rule, with a 60-day advance period, would apply to therelease of intergeneric microorganisms into the environment forcommercial research and development field trials.The proposed rule exempts certain microorganisms from the newnotification requirements, including: microorganisms that arecommonly used in contained fermentation systems in the manufactureof specialty chemicals; microorganisms with "permissible geneticmodifications" that are field-tested in sites of no more than 10 acres;and intergeneric microorganisms that are tested in contained structuressuch as laboratories and greenhouses (although researchers would stillneed to keep records).The EPA has estimated that industry-wide incremental costs ofcomplying with the new policy could climb as high as $2.2 million inthe first year but could drop to a quarter of that by the fifth year. Theagency predicted that costs would drop "as industry becomes morefamiliar with the provisions."EPA press officer Al Heier told BioWorld that the 160-page TSCAbiotechnology rule proposal will be published in the Federal Registerthis week and open for industry and public comment. Final rules willbe issued about a year from now."These biotechnology rules meet the Clinton Administration'scommitment to protect public health and the environment, whilemaking economic sense for the rapidly developing biotechnologyindustry," said EPA administrator Carol Browner in a preparedstatement. "Genetic engineering offers great potential for pollutionprevention by providing substitutes for traditional chemicals that maypose greater risks to health and the environment."Mycogen Corp.'s director of regulatory and environmental affairs, JoePanetta, offered a different view of the new regulations thanBrowner's. San-Diego-based Mycogen makes several products directlyimpacted by the proposed TSCA biotechnology rules. The companyhas developed a "CellCap" technology in which it uses microbes in afermenter to produce pesticide products.The CellCap process involves crossing a gene from Bacillusthuringiensis with a Pseudomonas fluorescens bacterium to create justthe type of intergeneric microorganism that EPA has proposedregulating. But Panetta argued that the microbe produced is no more orless dangerous than microbes produced by natural or chemicalmutation. In fact, he says that genetic engineering is a far more directedprocess, thus potentially safer, process than the other two."The EPA is singling out products produced through recombinantDNA technology as being somehow different scientifically," Panettatold BioWorld. "To say that chemical or physical mutation is OK butrecombinant mutation is not is just bad science."The EPA currently regulates microbial products of biotechnologyunder TSCA due to provisions of a 1986 policy called the"Coordinated Framework for Regulation of Biotechnology." Thepolicy defines the regulatory and oversight duties of variousgovernment agencies, including the FDA, the Department ofAgriculture and the EPA.Although TSCA was not designed to cover microbes, the EPA decidedthat intergeneric microorganisms represent a "new chemicalsubstance."In a related development on Thursday, the EPA published a final rule_ 10 years in the making _ for streamlining regulation of microbialpesticide testing under the Federal Insecticide, Fungicide andRodenticide Act. The new rule singles out only those pesticides that aredeemed by EPA to pose a serious risk to the public or the environment.n
-- Lisa Piercey Washington Editor
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